A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer

Acute Lymphoblastic Leukemia Clinical Trial

Official title:A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer

Status Recruiting

Clinical Trial Summary

Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric
malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed
to destroy malignant cell lines, and normal tissue is not always spared. While early
treatment- related organ specific toxicities are not always apparent, many childhood cancer
survivors report symptoms that interfere with daily life, including exercise induced
shortness of breath, fatigue and reduced capacity to participate in physical activity. These
symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most
commonly described in older adults; it indicates persons who are highly vulnerable to adverse
health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors
have at least one severe chronic health condition 30 years from diagnosis, why childhood
cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons,
and why they have mortality rates more than eight times higher than age-and-gender matched
members of the general population.

Frailty is a valuable construct because it can be distinguished from disability and
co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability
that identify individuals most at risk for adverse health outcomes. These investigators have
recently presented data indicating that impaired fitness is present in survivors of childhood
acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because
frailty, characterized by a cluster of five measurements of physical fitness, is predictive
of chronic disease onset, frequent hospitalization, and eventually mortality in both the
elderly and in persons with chronic conditions. Using a frailty phenotype as an early
predictor of later chronic disease onset will allow identification of childhood and
adolescent cancer survivors at greatest risk for adverse health. An early indicator of those
at risk for adverse health will allow researchers to test, and clinicians to provide,
specific interventions designed to remediate functional loss, and prevent or delay onset of
chronic health conditions. The investigators goals include characterizing physical frailty
over a five year time span in a population of young adult survivors of childhood cancer, as
well as assessing the association between frailty and the increase in the number and severity
of chronic health conditions.

Clinical Trial Description

PRIMARY OBJECTIVES:

- Evaluate the change in the proportion of young adult cancer survivors who are frail from
baseline to a point five years later.

- Evaluate the association between frailty and worsening of chronic health conditions.

- Describe the association between demographic and treatment factors and risk for
prevalent frailty.

- Estimate the effects of physical activity, diet and smoking on risk for prevalent
frailty.

Participants will complete a study questionnaire to assess social support, complete body
composition studies, walking speed test, physical activity monitoring, and difficulties in
daily activities due to health condition. In addition, any data collected as part of the
SJLIFE protocol, including questionnaires, medical history and physical, height and weight
measurements, physical functioning assessment results (i.e. hand grip strength), and
neuropsychological evaluation results, may also be used as part of the evaluation for this
study. The information collected for this study will be compared to information collected at
a previous SJLIFE clinic visit within the previous 6 years.
;

NCT02257684 -
A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)

NCT00866281 -
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

Phase 1/Phase 2

Share this page

Name

Send to

Message

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The data & information found on this website is provided “AS IS” from ClinicalTrials.gov.
Neither we, the United States Government, U.S. Department of Health and Human Services, National Institutes of Health, National Library of Medicine, nor any of its agencies, contractors, subcontractors or employees of the United States Government make any warranties, expressed or implied, with respect to data found on this site, and, furthermore, assume no liability, or the results of such use, of any part of the data.